(Q38087496)

28 August 2017

title

Scientific considerations in the review and approval of generic enoxaparin in the United States (English)

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28 August 2017

main subject

United States of America

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10

Janet Woodcock

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28 August 2017

4

Robert Lionberger

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28 August 2017

Sau Lee

1

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28 August 2017

Andre Raw

2

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28 August 2017

Lawrence Yu

3

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28 August 2017

Naiqi Ya

5

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28 August 2017

Daniela Verthelyi

6

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28 August 2017

Amy Rosenberg

7

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28 August 2017

Steve Kozlowski

8

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28 August 2017

Keith Webber

9

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28 August 2017

publication date

1 March 2013

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28 August 2017

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28 August 2017

volume

31

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28 August 2017

issue

3

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28 August 2017

page(s)

220-226

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Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety

28 August 2017

cites work

1 reference

Pharmacokinetic and pharmacodynamic properties of oral anticoagulants, especially phenprocoumon

21 January 2018

1 reference

Heparin and heparan sulfate: biosynthesis, structure and function

21 January 2018

1 reference

Enzymatic degradation of glycosaminoglycans

21 January 2018

1 reference

Heparin sequencing brings structure to the function of complex oligosaccharides

21 January 2018

1 reference

2003 Claude S. Hudson Award address in carbohydrate chemistry. Heparin: structure and activity

21 January 2018

1 reference

Heparin-protein interactions

21 January 2018

1 reference

Applying scientific criteria to therapeutic interchange: a balanced analysis of low-molecular-weight heparins

21 January 2018

1 reference

Liquid Chromatography/Mass Spectrometry Sequencing Approach for Highly Sulfated Heparin-derived Oligosaccharides

21 January 2018

1 reference

Chromatographic analysis and sequencing approach of heparin oligosaccharides using cetyltrimethylammonium dynamically coated stationary phases

21 January 2018

1 reference

Determination of the primary structures of heparin- and heparan sulfate-derived oligosaccharides using band-selective homonuclear-decoupled two-dimensional 1H NMR experiments

21 January 2018

1 reference

Rational design of low-molecular weight heparins with improved in vivo activity

21 January 2018

1 reference

Molecular cloning of the heparin/heparan sulfate delta 4,5 unsaturated glycuronidase from Flavobacterium heparinum, its recombinant expression in Escherichia coli, and biochemical determination of its unique substrate specificity

21 January 2018

1 reference

21 January 2018

1 reference

Mapping and quantification of the major oligosaccharide components of heparin

21 January 2018

1 reference

Chromatographic methods for product-profile analysis and isolation of oligosaccharides produced by heparinase-catalyzed depolymerization of heparin

21 January 2018

1 reference

Sequencing of 3-O sulfate containing heparin decasaccharides with a partial antithrombin III binding site

21 January 2018

1 reference

Sequencing complex polysaccharides

21 January 2018

1 reference

A strategy for rapid sequencing of heparan sulfate and heparin saccharides

21 January 2018

1 reference

Structural studies of octasaccharides derived from the low-sulfated repeating disaccharide region and octasaccharide serines derived from the protein linkage region of porcine intestinal heparin

21 January 2018

1 reference

Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy

21 January 2018

1 reference

Heparin enhances the specificity of antithrombin for thrombin and factor Xa independent of the reactive center loop sequence. Evidence for an exosite determinant of factor Xa specificity in heparin-activated antithrombin

21 January 2018

1 reference

Effects on molecular conformation and anticoagulant activities of 1,6-anhydrosugars at the reducing terminal of antithrombin-binding octasaccharides isolated from low-molecular-weight heparin enoxaparin.

21 January 2018

1 reference

Actions and Interactions of Antithrombin and Heparin

21 January 2018

1 reference

Management of oral anticoagulant therapy in Italy

21 January 2018

1 reference

Comparative pharmacokinetics of LMWHs

21 January 2018

1 reference

Risk for heparin-induced thrombocytopenia with unfractionated and low-molecular-weight heparin thromboprophylaxis: a meta-analysis

21 January 2018

1 reference

Heparin-induced thrombocytopenia: a prospective study on the incidence, platelet-activating capacity and clinical significance of antiplatelet factor 4/heparin antibodies of the IgG, IgM, and IgA classes

21 January 2018

1 reference

Heparin-induced thrombocytopenia: a review

21 January 2018

1 reference

Incidence and clinical relevance of anti-platelet factor 4/heparin antibodies before cardiac surgery

21 January 2018

1 reference

Platelet factor 4/heparin antibodies in blood bank donors

21 January 2018

1 reference

Mode of interaction between platelet factor 4 and heparin

21 January 2018

1 reference

Determinants of PF4/heparin immunogenicity

21 January 2018

1 reference

Surface plasmon resonance: applications in understanding receptor-ligand interaction

21 January 2018

1 reference

Analysis of non-covalent aggregation of synthetic hPTH (1-34) by size-exclusion chromatography and the importance of suppression of non-specific interactions for a precise quantitation

21 January 2018

1 reference

Modern analytical ultracentrifugation in protein science: a tutorial review

21 January 2018

1 reference

Field flow fractionation in biomedical analysis

21 January 2018

1 reference

Close approximation of two platelet factor 4 tetramers by charge neutralization forms the antigens recognized by HIT antibodies

21 January 2018

1 reference

Ultralarge complexes of PF4 and heparin are central to the pathogenesis of heparin-induced thrombocytopenia

21 January 2018

1 reference

Product individuality of commercially available low-molecular-weight heparins and their generic versions: therapeutic implications

21 January 2018

1 reference

A review of the two major regulatory pathways for non-proprietary low-molecular-weight heparins.

21 January 2018

1 reference

Recommendations on biosimilar low-molecular-weight heparins

21 January 2018

1 reference

SASAT (South Asian Society on Atherosclerosis & Thrombosis) proposal for regulatory guidelines for generic low-molecular weight heparins (LMWHs).

21 January 2018

1 reference

Differences of present recommendations and guidelines for generic low-molecular-weight heparins: is there room for harmonization

21 January 2018

1 reference

Overview on guidelines and recommendations for generic low-molecular-weight heparins.

21 January 2018

1 reference

US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins

21 January 2018

1 reference

Regulatory considerations for generic or biosimilar low molecular weight heparins

21 January 2018

1 reference

Combined Quantitative 1H and 13C Nuclear Magnetic Resonance Spectroscopy for Characterization of Heparin Preparations

21 January 2018

1 reference

Concentration-dependent roles for heparin in modifying liopolysaccharide-induced activation of mononuclear cells in whole blood

21 January 2018

1 reference

12 December 2020

Heparin-induced thrombocytopenia: IgG binding to PF4-heparin complexes in the fluid phase and cross-reactivity with low molecular weight heparin and heparinoid

1 reference

12 December 2020

Production and chemical processing of low molecular weight heparins.

1 reference

12 December 2020

In vitro studies on the biochemistry and pharmacology of low molecular weight heparins.

1 reference

12 December 2020

Characterization of the structural requirements for a carbohydrate based anticoagulant with a reduced risk of inducing the immunological type of heparin-associated thrombocytopenia.

1 reference

12 December 2020

A comparative study of three low-molecular weight heparins (LMWH) and unfractionated heparin (UH) in healthy volunteers

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12 December 2020

Structural features of low-molecular-weight heparins affecting their affinity to antithrombin.

1 reference

12 December 2020

Heparin and enoxaparin enhance endotoxin-induced tumor necrosis factor-alpha production in human monocytes

1 reference

12 December 2020

Prevention of deep vein thrombosis after hip replacement--comparison between two low-molecular heparins, tinzaparin and enoxaparin.

1 reference

12 December 2020

Heparin-induced thrombocytopenia

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12 December 2020

Minimal sequence in heparin/heparan sulfate required for binding of basic fibroblast growth factor

1 reference

12 December 2020

Developing the nation's biosimilars program

1 reference

12 December 2020

Identifiers

DOI

10.1038/NBT.2528

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28 August 2017

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